Benign and malignant tumors can occur in the pelvis. For example, uterine leiomyomata, are muscle cell tumors that occur in 77% of women in the reproductive years. Although uterine leiomyomata rarely (0.1%) progress to cancer, these tumors can cause excessive menstrual bleeding, irregular bleeding, pregnancy loss, infertility, urinary frequency, and pelvic pressure or pain with sexual activity, menses, or daily activities. Women with uterine leiomyomata frequently incur surgical procedures (e.g., hysterectomy, dilatation and curettage, myomectomy, and hysteroscopy), medical and hormonal therapies, office visits, and a variety of radiologic procedures (e.g., ultrasounds, CAT scans, and MRIs), in an effort to treat these tumors. Uterine leiomyomata account for approximately 200,000 hysterectomies per year in the United States alone, at a direct cost of well over $2 billion. Hysterectomies carry a morbidity rate of 1%, with 2,000 deaths per year and 240,000 complications per year in North America.
Uterine leiomyomata are most often multiple, and may be subserosal (i.e., bulging externally from the uterus), intramural (i.e., growing entirely within the wall of the uterus), submucosal (i.e., hidden within the uterine cavity), or pedunculated (i.e., growing outward with a stalk-like base). Because patients may have multiple uterine leiomyomata at different locations, conservative surgeries may involve both an abdominal and a vaginal (hysteroscopic) approach, thereby necessitating two procedures.
Investigators have utilized a laser or bipolar cautery to perform myolysis or destruction of these tumors, although neither of these methods is performed in significant numbers today. These methods necessarily destroy normal overlying tissue in order to treat the underlying tumor. As a result, the integrity of the uterus is compromised, and harmful scar tissue (e.g., adhesions) may occur. Thus, there is a need for an improved method of treating benign and malignant pelvic tumors that does not damage the overlying tissue. Such an improved method could be used on women who wish to later conceive and subsequently deliver. There is also a need for a single method capable of treating all sizes of subserosal, intramural, submucuosal, and pedunculated tumors in all locations. A single method, which would relieve most or all symptoms of abdominal or pelvic pain/pressure, abnormal uterine bleeding, urinary frequency, infertility, and miscarriage, is also needed. In addition, it would be desirable for the method to be less invasive, cheaper, and safer than conventional methods of treating pelvic tumors, and also to allow for uterine preservation.